Job Summary
A healthcare company has an open position for a Remote Senior Chemistry Manufacturing and Controls Documentation Specialist.
Core Responsibilities of this position include:
- Applying required Submission Readiness document formatting to authored CMC content
- Managing and prioritizing all workload according to CMC SPA
- Supporting CMC/Author Strategists
Skills and Requirements Include:
- Bachelor's (or equivalent) and 2-4 years of experience or equivalent experience or education
- cGMP and compliance requirements knowledge
- General knowledge of Global regulatory submissions and publishing requirements
- ICH CTD (Common Technical Document) requirements knowledge
- Computer literacy with Microsoft Office Suite and Documentum-based applications
- Ability to read and interpret complex business and/or technical documents